Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie’s Disease

Ziegelmann, Matthew; Viers, Boyd R.; McAlvany, Kelly L.; Bailey, George C.; Savage, Joshua; Trost, Landon

doi:10.1016/j.juro.2015.10.065

Cited by 81 publications

(41 citation statements)

References 19 publications

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“…All curvature measurements were then summed to define a composite curvature measure, as described previously. 15 In cases of penile rotation, the penis was reoriented to a neutral position such that the glans and urethral meatus appeared in the normal, orthotopic position. With this maneuver, a curvature may initially appear to be dorsolateral but actually may be a pure dorsal curvature with rotation.…”

Section: Questionnaires and Objective Assessmentsmentioning

confidence: 99%

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Alom¹,

Sharma²,

Toussi³

et al. 2019

The Journal of Sexual Medicine

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Background: Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. Aim: To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. Methods: A prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). Outcomes: Changes in penile length, curvature, and subjective perception and the occurrence of adverse events. Results: Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3 /31% for group 1, 19.2 /30% for group 2, and 33.8 / 49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and þ1.9 cm/þ17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience 20 , 20%, and 50% curvature improvements, 1 cm length gain, and 20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of 3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve 20 curvature improvement, and 3.5 times more likely to achieve 50% curvature improvement, and 10.7 times more likely to experience 20% length improvement. Adverse events were similar among the 3 groups. Clinical Implications: Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. Strengths & Limitations: Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. Conclusion: The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and R...

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Section: Questionnaires and Objective Assessmentsmentioning

confidence: 99%

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Alom¹,

Sharma²,

Toussi³

et al. 2019

The Journal of Sexual Medicine

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“…These methods have previously been described and published elsewhere. 19 Depending on specific patient criteria, all were counseled regarding each of the 3 treatment options outlined below. Patients with an identifiable plaque on ultrasound scanning and curvature !30 were considered eligible for treatment with CCH.…”

Section: Treatment Cohortsmentioning

confidence: 99%

Comparative Cost-effectiveness of Surgery, Collagenase Clostridium Histolyticum, and Penile Traction Therapy in Men with Peyronie’s Disease in an Era of Effective Clinical Treatment

Wymer

Köhler

Trost

2019

The Journal of Sexual Medicine

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Background: Traditionally, surgery has been considered the gold standard treatment for Peyronie's disease (PD). Less-invasive alternatives, such as collagenase Clostridium histolyticum (CCH) and traction therapy, have been proposed and proven effective. Aim: To compare cost-effectiveness of management options for PD. Methods: A Markov analytic model was created to compare the cost-effectiveness of treatment with a novel traction device, RestoreX (RXPTT), vs CCH vs surgery. Outcomes were derived from single-institution, prospective data of 63 men treated with RXPTT, 115 with CCH, and 23 with plication or incision and grafting. Costs were based on 2017 Medicare reimbursement and utility values from the literature. Main Outcome Measures: Model outcomes included complications for each treatment arm, as well as the probability of success, which was defined as !20% improvement in curvature. Univariable and multivariable sensitivity analyses were performed to test the robustness of the model. Results: Overall success rates were 96% (surgery), 66% (CCH), and 48% (RXPTT). At 10 years after treatment, RXPTT was the most cost-effective, with mean costs per patient of $883 (RXPTT), $11,419 (surgery), and $33,628 (CCH). CCH and surgery both resulted in a gain of quality adjusted life years (QALYs) relative to RXPTT (9.44 and 9.36 vs 9.27, respectively). Sensitivity analysis demonstrated greater cost-effectiveness for surgery if lower (46%) rates of postoperative erectile dysfunction or length loss (3%).

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“…Since the publication of the IMPRESS I and II studies [7], CCH therapy for PD has entered into clinical practice for most groups of urologists specializing in PD. Indeed, several groups have already provided preliminary and medium-term results on the efficacy of this treatment [8,11,12,[23][24][25][26][27], some of them with modifications to the protocol used in the IMPRESS studies (Table 3).…”

Section: Discussionmentioning

confidence: 99%

Optimizing collagenase Clostridium histolyticum therapy for Peyronie’s disease using a novel approach with percutaneous needle tunnelling

et al. 2019

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Objectives To compare the efficacy and safety of a combined treatment of percutaneous needle tunnelling (PNT) and a modified collagenase Clostridium histolyticum (CCH) protocol (PNT/CCH) vs the modified protocol alone (CCH) in the treatment of Peyronie's disease (PD). Patients and Methods A prospective registry of patients treated with a modified CCH protocol was maintained between June 2014 and February 2018. The last 50 patients received PNT as an adjuvant therapy (PNT/CCH), and their data were compared with those of the other 94 patients treated previously (CCH). PNT involves the creation of multiple holes made percutaneously in the plaque before each injection. The modified protocol consisted of two collagenase injections, at 1‐week intervals, followed by penile modelling. Patients used penile traction therapy, tadalafil and pentoxifylline for the next 2 months and were followed up for 6 months. The main outcome was improvement of curvature. Secondary outcomes were improvements in erectile function, PD symptoms, stretched penile length and satisfaction. Results Improvement in curvature was greater in patients in the PNT/CCH group than in the CCH group (mean ± sd 19.2 ± 6.1° vs 12.7 ± 5.0°; P < 0.001 [36.2 ± 12.5% vs 28.1 ± 14.5%; P = 0.001]). Compared with baseline, both interventions were associated with significant improvement in secondary outcomes. The main complications were ecchymosis, bruising and penile pain, with no significant differences between groups. Conclusions Treatment of PD with CCH using our modified protocol in combination with PNT is safe and more effective than the modified protocol alone, with the potential for improved cost‐effectiveness.

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Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie’s Disease

Cited by 81 publications

References 19 publications

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Comparative Cost-effectiveness of Surgery, Collagenase Clostridium Histolyticum, and Penile Traction Therapy in Men with Peyronie’s Disease in an Era of Effective Clinical Treatment

Optimizing collagenase Clostridium histolyticum therapy for Peyronie’s disease using a novel approach with percutaneous needle tunnelling

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